NCT06127407 · Servier Bio-Innovation LLC
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
(CHONQUER)
What this study is about
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, conducted at multiple hospitals, where neither patients nor doctors know which treatment is given, randomly assigned, compared against an inactive treatment study of taken by mouth administered ivosidenib.
View original scientific description
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase.
Interventions
DRUG
Ivosidenib 500mg
Provided as tablets, taken orally as two 250mg tablets once daily.
DRUG
Placebo
Provided as tablets, taken orally once daily.
Primary outcome measures
Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants
Time frame: Up to approximately 31 months
From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
- Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1. Participants who have received prior radiation therapy are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
- Have received 0 or 1 prior systemic treatment regimen in the advanced/metastatic setting for chondrosarcoma.
- Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as: 1. Radiographic progression of disease (local and/or distant) documented by 2 imaging assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization. OR 2. Any recurrence of disease (loca
Where
- Los Angeles, California
- Santa Monica, California
- Aurora, Colorado
- New Haven, Connecticut
- Jacksonville, Florida
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
- Baltimore, Maryland
- Boston, Massachusetts
- Rochester, Minnesota
And 10 more locations — see the full list below.
Collaborators
Institut de Recherches Internationales Servier
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations